Pilot Study assessing blood flow changes in patients with hypertensive heart failure fitted with an Extra Aortic Counterpulsation Device (BioQ CA) acutely attached to the ascending aorta in the open chest

BIOQ DEVICES PTY LTD0 个研究点目标入组 40 人开始时间: 2021年2月26日最近更新: 2021年5月24日

适应症

试验速览

暂无简介。

•Inclusion criteria will include
•Adults of 18 years or over
•Patient has read and signed the informed consent prior to study related procedures
•Willing and able to comply with all required follow-up evaluations and assessments
•Patients scheduled for Coronary Artery Bypass Grafting (CABG) will be assessed for:
•1) hypertension and ejection fraction (EF) cut-offs defined below,
•2) Presence of heart failure ( Class I to IV),
•3) coronary artery disease,
•4) aortic stiffness,
•5) stroke risk,
•6) valve dysfunction,
•7) aortic calcification and atherosclerosis
•8) ischemia/non-ischemia classification.
•oGroup 1 will consist of up to 20 patients with hypertensive heart failure PLUS low ejection fraction (30% - 45% EF).
•oGroup 2 will consist of up to 20 patients with hypertensive heart failure PLUS preserved ejection fraction (>50% EF).

•Exclusion criteria will include:
•history of previous stroke,
•significant mitral and or aortic valve disease/dysfunction,
•ascending aortic disease calcification or atherosclerosis or aneurysm.
•intraoperative echo or epi-aortic ultrasound will be used during the surgical procedures to exclude or confirm presence of severe aortic disease before applying the device as a final precautionary measure prior to placement. Patients will be excluded at this point if they are confirmed in the exclusion criteria.

发起方

BIOQ DEVICES PTY LTD